Creon 10000

Active Ingredients

Each capsule contains:

Pancreatin 150 mg equivalent to:

Lipase 10,000 Ph. Eur. u

Amylase 8,000 Ph. Eur. u

Protease 600 Ph. Eur.u

Indications

Therapeutic group:

Digestive enzymes

Creon 10,000 contains pancreatic enzymes which aid digestion, in cases where the pancreas does not produce these enzymes, or does not produce enough of them. The medicine is intended to balance low enzymatic activity in the intestine, in cases of pancreatic insufficiency, e.g., as in cystic fibrosis, chronic pancreatitis.

Instructions

Swallow the capsules whole with a little water. Do not chew or crush the capsule so as not to destroy the inner coating within which the enzymes are enclosed and thus nullify the enzymatic activity of the medicine.

When there is difficulty in swallowing the capsules whole, it is possible to open them carefully and mix their contents with soft acidic food or with an acidic drink. Yogurt and applesauce are examples for soft acidic food. An acidic drink can be apple, orange or pineapple juice. In the event that the contents of the capsules are mixed with food or drink, the mixture must be swallowed immediately, without crushing or chewing , so that the inner coating will not dissolve. Do not keep the mixture. Mixing the contents of the capsule with non-acidic food or drink may cause irritation in your mouth or change the way Creon works in your body.

Do not keep the whole capsule or the mixture in your mouth for longer than the time required to swallow it.

Take the medicine while eating a meal or a snack or right after having a meal or a snack.

The dosage is according to doctor's instructions. Do not exceed the recommended dose.

If you forget to take the dose on time, skip it and do not take a dose until the next meal.

During treatment with this medicine, make sure to maintain adequate fluid intake at all times, especially at a time of increased loss of fluids (e.g., vomiting and diarrhea). Not drinking adequately may exacerbate constipation. It is important to drink a lot of fluids every day!

How can you contribute to the success of the treatment?

Complete the full course of treatment as recommend by the doctor. Even if there is an improvement in your health, do not discontinue use of this medicine without consulting a doctor.

Warnings

Do not use Creon 10,000 if there is a known sensitivity to any of its ingredients or to porcine protein.

Fibrosing colonopathy (colonic-strictures) has been reported in cystic fibrosis patients who are taking preparations that contain high doses of pancreatin. Nonetheless, if you suffer from cystic fibrosis and are taking doses higher than 10,000 lipase units per kilogram of body weight per day, when unusual abdominal symptoms or changes in regular abdominal symptoms occur, refer to the doctor.

Creon 10,000 contains pancreatin that is extracted from pancreatic tissue from swine raised for food consumption, like other marketed preparations that contain pancreatin of porcine origin. Although the risk for transmission of an infectious agent to humans through Creon 10,000 is reduced by testing and inactivation of certain viruses, carried out during manufacture of the preparation, there is a theoretical risk for transmission of a viral disease, including diseases caused by novel or unidentified viruses. The presence of such viruses that might infect humans cannot be completely ruled out. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic enzymes have been reported.

Do not take this medicine without consulting a doctor before starting treatment:

If you are pregnant or breastfeeding (the medicine can be used while breastfeeding).

If you are taking another drug , including non-prescription medicines and food supplements, or if you have just finished treatment with another medicine, inform the attending doctor, in order to prevent hazards or lack of efficacy arising from drug interactions.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist. Read the patient package insert carefully before starting to take any medication.